510(k) K153693

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code LAF

K153693 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators". The FDA issued a decision of Substantially Equivalent on March 18, 2016. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Immunalysis Corporation has at least 10 other 510(k) clearances on record.